Regulatory Rabbit Holes – Medical Devices

Originally, I was going to write a completely different post that would look in depth at the specific differences between UK and EU medical device regulations and what they mean for manufacturers. Halfway through, I fell into the same trap that I, and I know many others, have fallen into before: chasing a definitive point down a regulatory rabbit hole.

A regulatory rabbit hole is a series of searches through standards and regulations in search of a definitive answer to a very specific question. Each step (each Google search) leads to another cryptic reference and a reference to another piece of legislation or MDCG document.

This search usually ends with an ambiguous answer that is open to interpretation. This puts the onus back on your regulatory department/consultant to justify the position taken in the technical documents

regulatory rabbit holes

Image by John F from Pixabay

The regularity with which these issues appear speaks to the current state and changing nature of medical device regulation in both the UK and EU. Having moved away from the established and stable security blanket of the MDD, we as regulatory teams are still exploring the nuances of EU MDR /IVDR six years after its original publication. Competent authorities, notified bodies and the European Commission are still finding the right interpretations now that the regulations are being applied to real life and a wide variety of devices.

This interpretation issue also affects product regulations in the United Kingdom. The delays in the new UK medical device regulations mean that CE labelling is by far the most common method of accessing the UK market. The current UK MDR refers directly to EU legislation (MDD, AIMD and IVDD), and the UK accepts CE marks under EU MDR /IVDR along with the extended MDD/IVDD certificates under Article 120. As interpretation changes, so does the technical documentation to reflect this change in thinking. The UK regulations still seem a long way off, but if the timelines remain as they are, we are only two years away from full adoption of the new UK regulations. It remains to be seen how the nuances in the regulatory world will affect this.

How best to deal with unclear regulations and regulatory rabbit holes? Experience is key. You have to know your target, make a reasoned and risk-averse argument, and sometimes you need a little luck. It seems odd to talk about luck when it comes to evaluating legislation, but we should acknowledge that it is a factor. No two assessors are the same, whether it’s a competent authority assessor or a notified body assessor. Each has their own skills, their own preferences, and – controversially – a different level of scrutiny.

So, good luck chasing your regulatory rabbits. Remember, if you do come across a wily old fox on Elsmar or similar forums, double-check before presenting any arguments to the regulators!

JensonR+ is an established technical consultancy. Our Medical device consultants have years of experience working with notified bodies, UK approved bodies and several competent authorities including MHRA. For help navigating your own regulatory conundrums please contact us.
Tom Wood
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